Acute and 90-day toxicological safety assessment of Shang-Ke-Huang-Shui lotion in New Zealand White rabbits

Shang-Ke-Huang-Shui lotion (SKHS), an experiential formula based on the theory of traditional Chinese medicine as a hospital preparation, combines Coptidis Rhizoma, Phellodendri Chinensis Cortex, Gardeniae Fructus, Arnebiae Radix, Menthae Haplocalycis Herba and Alumen. While it has acquired positive effects on the treatment of soft tissue injuries, there is no systematic safety assessment in recent studies.The study aimed to investigate the acute and long-term toxicity in New Zealand White rabbits using topical administration of SKHS.In the acute toxicity study, rabbits were given topical administration of SKHS extract (2.775 g crude drug/mL) 3 times daily in normal and broken skin. In the long-term toxicity study, rabbits underwent topical administration of SKHS extract (1.390, 0.694, 0.139 g crude drug/mL) 1 time per day in normal and broken skin for 90 days. Their general behavior, body weight, food intake, biochemical and hematologic parameters, organ coefficients, and pathological morphology were analyzed.Mild skin irritation was observed in rabbits with normal or broken skin following acute exposure to the high dose of SKHS. Evidence of toxicity was not observed in the rabbits exposed to SKHS for an extended period. Although some parameters have been significant changes, they cannot be considered treatment-related because they have remained within normal limits.Topical administration of SKHS could be considered relatively safe and did not reveal any severe toxicity or side effects in this study.